Hartford Physicians Management Corp

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to test the Proficiency Testing (PT) samples in the same manner as patient samples that are being tested by only one Testing Personnel (TP) in the specialty of Immunohematology. Findings Include: 1. Record review on 11/30/2023 of the "Daily Log" revealed the patient result log with one result only. 2. Record review on 11/30/2023 of the "AAB-Medical Laboratory Evaluation (MLE) Proficiency Testing Personnel Results" worksheet revealed the PT samples being tested by multiple TP's for the same event as follows: a. Event 1 Nonchemistry M1 2023: tested by Four TP. b. Event 2 Nonchemistry M2 2023: tested by Two TP. c. Event 3 Nonchemistry M3 2023: tested by Two TP. 3. Staff interview on 11/30/2023 at 09:45 AM with the Clinical Manager and TP # 1 confirmed the process to perform PT samples was one of the TP would perform the test on all the specimens, read and document the results on the worksheet. The other TP would then read the slides and document their results on the worksheet tested by the previous TP. Once all the TP's have the documented their results on the worksheet, the answers would be verified against each other and then submitted to AAB- MLE. He/She further confirmed that the patient sample is tested and resulted by only one TP with patient present in the room. 4. The laboratory perfoms 600 tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and staff interview the laboratory failed to enroll in proficiency testing (PT) for the specialty of immunohematology. Findings include: 1. Record review on 11/20/19 of the Certification and Survey Provider Enhanced Reporting Report 0096D revealed no PT scores reported for D (RHO) 2019 events 1, 2 and 3. 2. Record review of the CLIA application test menu on 11/20/19 revealed the laboratory performed the above test in 2018 and 2019. 3. Record review on 11/20/19 of the laboratory's PT records revealed the laboratory did not participate in PT in 2019. 4. Staff interview on 11/20/19 at 9:23 AM with the Clinic Administrator (CA) confirmed the above findings. The CA stated the laboratory recently had staff turnover and PT enrollment was an oversight. The CA also stated he/she tried to enroll when the oversight was discovered but was told by the PT company it was too late. 5. The laboratory performs 2,000 D (RHO) tests annually in the specialty of immunohematology. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --